Director, Clinical Science, Oncology

Moderna; Princeton (NJ); Hybrid; USD 120,000 - 220,000; Full time

Job summary

An established industry player is seeking a Director of Clinical Science in Oncology to lead critical clinical studies. This pivotal role involves ensuring data quality, collaborating on regulatory strategies, and mentoring junior staff. The ideal candidate will possess extensive oncology expertise and a strong background in clinical development. Join a forward-thinking organization that values innovation and teamwork, offering a flexible work model and a commitment to diversity and inclusion. Make a significant impact in the healthcare sector and contribute to groundbreaking advancements in medicine.

Benefits

Comprehensive Healthcare

Well-being Resources

Generous Time Off

Family Benefits

Diversity and Inclusion Commitment

Qualifications

• 10+ years of clinical development experience with a focus on oncology.
• Strong understanding of regulatory standards and clinical trial design.

Responsibilities

• Oversee and execute Phase 1-3 clinical studies in oncology.
• Collaborate with Clinical Development Lead on trial design and strategy.

Skills

Oncology Expertise

Clinical Development

Regulatory Compliance

Data Integrity

Communication Skills

Education

PhD, PharmD, or Master's Degree

Advanced Nursing Degree

Job description

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The Role

This role will support Oncology Therapeutic programs, specifically supporting the Clinical Development Lead in the direction, execution, and evaluation of Phase 1-3 clinical studies. The principal responsibility for this role is ensuring the comprehensive data quality of clinical studies to support internal governance decisions and regulatory submissions.

Here’s What You’ll Do

1. Contribute to regulatory and clinical program strategy, trial design, and execution in collaboration with the Clinical Development Lead and team.
2. Author and review clinical documents in compliance with regulatory standards, including protocols, informed consent forms, DSURs, Investigator Brochures, INDs, and marketing applications.
3. Oversee clinical studies, lead when appropriate, review data, and ensure timely deliverables.
4. Support site management and safety decisions in collaboration with Clinical Safety & Pharmacovigilance.
5. Participate in study start-up, execution, and inspection readiness activities with Clinical Operations.
6. Develop messaging and content for Investigator Meetings and Advisory Boards.
7. Train and mentor junior Clinical Science personnel.
8. Contribute to evolving clinical science processes and trial delivery models.

Here’s What You’ll Need

• High ethical standards and commitment to excellence.
• Strong scientific and clinical oncology expertise.
• Experience operating in matrix environments with excellent communication skills.
• Ability to contribute to early and late-stage programs across multiple functions.

Here’s What You’ll Bring

• Teamwork skills and ability to work collaboratively.
• PhD, PharmD, Master’s, or advanced nursing degree with significant oncology and drug development experience.
• At least 10 years of clinical development experience.
• Expertise in study design, data integrity, analysis, and presentation.
• Excellent communication and presentation skills.
• Willingness to travel up to 15%.
• Based in Cambridge, MA, or Princeton, NJ, with a flexible in-office schedule.

Benefits and Culture

Moderna offers comprehensive healthcare, well-being resources, family benefits, generous time off, and a commitment to diversity and inclusion. We foster a collaborative, innovative environment with a 70/30 in-office work model to promote teamwork and mentorship.

About Moderna

Founded in 2010, Moderna is a leader in mRNA technology, dedicated to transforming medicine. We value innovation, diversity, and community impact, striving to create a culture of belonging and excellence. Join us to make a difference in healthcare worldwide.